NCT06728527招募中不适用
PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,001
- 试验地点
- 1
- 主要终点
- Surgical Complications
研究概览
简要总结
The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.
详细描述
The Main Outcomes and Measures are:
A) Patient Demographics and Tumour characteristics
- Patient demographics: age, body mass index (BMI), comorbidities
- Preoperative tumour characteristics and location influencing surgical planning
B) Treatment characteristics
- Surgical: operative data, including flap types and distribution
- Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing partial breast reconstruction using CWPF for primary breast cancer
- •Delayed correction of breast deformity following previous BCS
- •Each surgeon is to have performed a minimum of 10 CWPFs
- •Each centre anticipates completing a minimum of 10/year
排除标准
- •Patients undergoing volume displacement BCS
- •Patients undergoing mastectomy +/- immediate breast reconstruction
结局指标
主要结局
Surgical Complications
时间窗: Within 30 days of surgery
Outcomes: • Rates of complications (e.g., Haematoma, Seroma, Infection, Delayed Wound healing, Fat necrosis, Flap loss, etc). Measures: • Complication rates stratified by severity (e.g., Clavien-Dindo classification).
次要结局
- Oncological Clearance(From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.)
- Revisional surgery(From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.)
- Oncological: Recurrence(From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months)
- Oncological: Survival(From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months)
研究者
Amit Agrawal
Consultant Oncoplastic Breast Surgeon
Cambridge University Hospitals NHS Foundation Trust
研究点 (1)
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